Regimens of misoprostol with mifepristone for early medical abortion: a randomised trial

OBJECTIVE: To compare the efficacy, adverse effects and acceptability of the three most common misoprostol regimens used with mifepristone for medical abortion. DESIGN: Randomised nonblinded trial. SETTING: Three clinics associated with major research universities in Canada; two in major urban areas and one in a periurban area. POPULATION: Women of reproductive age. METHODS: Consenting women presenting for abortion services with gestations less than 56 days and who met inclusion criteria were given 200 mg mifepristone orally and then randomised into three misoprostol study groups: (group I) 400 micrograms of oral misoprostol, (group II) 600 micrograms of oral misoprostol, and (group III) 800 micrograms of vaginal misoprostol. Misoprostol was self-administered at home 24-48 hours following mifepristone, and participants were instructed to take a second similar misoprostol dose at 24 hours after the initial dose if bleeding was less than a normal menstrual period. MAIN OUTCOME MEASURES: Successful abortion without surgery was 94.1%, with no significant differences across the three study groups (94.7% in group I, 93.4% in group II, and 94.3% in group III; P= 0.975). RESULTS: Efficacy and adverse effects did not differ significantly across the three study groups. Pain increased significantly across the study and the gestational age groups and was associated with lower acceptability. CONCLUSIONS: There appears to be a range of safe and effective options for early medical abortion with mifepristone including a choice between oral and vaginal administration of misoprostol.     

Spontaneous abortion: a randomized, controlled trial comparing surgical evacuation with conservative management using misoprostol

Objective: To compare the efficacy of surgical evacuation of the uterus with medical evacuation using misoprostol in cases of spontaneous abortion.

Design: A prospective, randomized, controlled trial.

Setting: A university teaching hospital.

Patient(s): Six hundred thirty-five women who aborted spontaneously and who consented to pretreatment randomization.

Intervention(s): Routine surgical evacuation or medical evacuation of the uterus using misoprostol.

Main Outcome Measure(s): Immediate, short-term (2–3 weeks), and medium-term (6 months) medical complications.

Result(s): There was a significantly lower incidence of immediate and short-term complications in the group treated with misoprostol compared with the surgically treated group. There were also fewer major complications in the 6 months after treatment in the medically treated group. Approximately 50% of the medically treated group subsequently required surgical evacuation, and these subjects required significantly more analgesia.

Conclusion(s): Treatment with misoprostol can reduce the demand for surgical evacuation in cases of spontaneous abortion, and its use is associated with fewer medical complications.     

A randomized comparison of mifepristone and self-administered oral or vaginal misoprostol for early abortion.

In France, mifepristone in association with orally administered misoprostol is widely used for the early termination of pregnancy (up to 49 days' gestation). In other centers, mifepristone in association with vaginally administered misoprostol has also been used. The aim of the present study was to compare the efficacy and tolerance of mifepristone in association with misoprostol administered orally or vaginally for the termination of pregnancy of up to 49 days' gestation. A total of 237 women were enrolled in the study. All women received 600 mg mifepristone administered orally and 400 microg misoprostol administered either orally (n = 119) or vaginally (n = 118). A second dose of 400 microg misoprostol was administered if women had not expelled the pregnancy within 3 h. Women were randomized into treatment groups according to the day of their admission. The overall success rate was 98.7% and there was no significant difference in efficacy between the two groups. There was one treatment failure in the group in which misoprostol was administered orally. Of those women who aborted within 3 h of administration of the first dose ofmisoprostol, the route of administration ofmisoprostol did not influence the time to abortion. Of the women who received a second dose ofmisoprostol, the time to abortion was shorter in those who received misoprostol orally (52 min versus 77 min). Tolerance was assessed by visual analog scales and was similar for both groups. In both groups, women preferred the oral route of administration.     

A randomized comparison of mifepristone and self-administered oral or vaginal misoprostol for early abortion

In France, mifepristone in association with orally administered misoprostol is widely used for the early termination of pregnancy (up to 49 days' gestation). In other centers, mifepristone in association with vaginally administered misoprostol has also been used. The aim of the present study was to compare the efficacy and tolerance of mifepristone in association with misoprostol administered orally or vaginally for the termination of pregnancy of up to 49 days' gestation.

A total of 237 women were enrolled in the study. All women received 600 mg mifepristone administered orally and 400 μg misoprostol administered either orally (n = 119) or vaginally (n = 118). A second dose of 400 μg misoprostol was administered if women had not expelled the pregnancy within 3 h. Women were randomized into treatment groups according to the day of their admission.

The overall success rate was 98.7% and there was no significant difference in efficacy between the two groups. There was one treatment failure in the group in which misoprostol was administered orally. Of those women who aborted within 3 h of administration of the first dose of misoprostol, the route of administration of misoprostol did not influence the time to abortion. Of the women who received a second dose of misoprostol, the time to abortion was shorter in those who received misoprostol orally (52 min versus 77 min).

Tolerance was assessed by visual analog scales and was similar for both groups. In both groups, women preferred the oral route of administration.     

Medical abortion with mifepristone and misoprostol: a clinical trial in Taiwanese women.

BACKGROUND AND PURPOSE: Medical abortion was not officially approved in Taiwan until the end of 2001. We investigated the efficacy of combination mifepristone and misoprostol therapy for medical abortion (which has now been approved) in early pregnant Taiwanese women and whether the attitudes of women who received this treatment affected the clinical outcome of medical abortion. METHODS: Eighty healthy women in early pregnancy (< 49 d of gestation) were enrolled into two studies of medical abortion using mifepristone and misoprostol regimens. The outcomes were evaluated based on complete expulsion of intrauterine contents, with or without surgical intervention. Study 1 used treatment with mifepristone (200 mg or 600 mg) and misoprostol (400 micrograms), and the decision to perform surgical intervention was made mainly on the basis of the patient's request. Study 2 used treatment with mifepristone (200 mg or 600 mg) and misoprostol (600 micrograms) where the decision to perform surgical intervention was made exclusively by the physician. Serum or urinary human chorionic gonadotropin (hCG) concentration was measured serially after abortion. RESULTS: In general, the success rate was 95% as judged by complete expulsion of intrauterine contents without surgical intervention. However, the success rate in Study 1 was only 62.5%. The mean duration of bleeding after abortion was 16.7 to 21.7 days. Serum or urinary hCG concentration remained positive in one woman (1.2%) studied during 43 to 60 days after abortion. CONCLUSION: A combination of mifepristone and misoprostol for medical abortion in Taiwanese women during early pregnancy can achieve a high success rate. Our study showed that a mifepristone dose of 200 mg and a misoprostol dose of 400 micrograms were most effective. Our results suggest that sufficient physician and patient communication regarding medical abortion affects the clinical outcome.     

A randomised controlled trial of mifepristone in combination with misoprostol administered sublingually or vaginally for medical abortion up to 13 weeks of gestation

OBJECTIVE: To assess women's acceptability, the efficacy and side effects of sublingual versus vaginal administration of misoprostol in combination with mifepristone for medical abortion up to 13 weeks of gestation. DESIGN: Randomised controlled trial. SETTING: Aberdeen Royal Infirmary. POPULATION: Women undergoing medical abortion under the terms of the 1967 Abortion Act. METHODS: Mifepristone (200 mg) was given orally followed 36-48 hours later by misoprostol administration (sublingual: 600 microg; vaginal: 800 microg). A second dose of misoprostol 400 microg was given 3 hours later (sublingually or vaginally). Women between 9 and 13 weeks of gestation received a further (third) dose of misoprostol 400 microg (sublingually or vaginally), 3 hours later if abortion had not occurred. MAIN OUTCOME MEASURES: Women's acceptability, efficacy of the regimen and side effects experienced. RESULTS: A total of 340 women were recruited (171 sublingual and 169 vaginal). A total of 70% of women in the sublingual group expressed satisfaction with the route of misoprostol administration; 18% answered 'Don't know' while 12% were dissatisfied, compared with 68%, 28% and 4%, respectively, in the vaginal group (P= 0.02). There was no significant difference in the need for surgical evacuation for women in the sublingual (3/158, 1.9%) and vaginal groups (4/156, 2.6%) (P= 0.70). Women receiving misoprostol sublingually were more likely to experience diarrhoea (P < 0.01), shivering (P < 0.01) and unpleasant mouth taste (P < 0.01). CONCLUSIONS: Sublingual administration of misoprostol is an effective alternative to vaginal administration for medical abortion up to 13 weeks of gestation. The prevalence of prostaglandin-related side effects, however, was higher with this route of administration.     

Medical abortion with mifepristone and misoprostol: study of the efficacy,somatic tolerance and perception of medical abortion

STUDY DESIGN: This prospective study examined the efficacy and somatic tolerance as well as the perception of the different phases of medical abortion with mifepristone and misoprostol. The subjective influence of counseling and accompanying on perception and psychic sequelae was evaluated. METHOD: The somatic data of the patients who had a medical abortion at Basel University Hospital of Gynecology and Obstetrics from December 1, 1999, to October 31, 2000, were identified in the case records. A questionnaire at the time of the abortion and a structured interview by telephone 6 months later were used to assess the perception of the abortion. RESULTS: Abortion with mifepristone and misoprostol was successful in 95.2% of cases. Counseling and accompanying were considered supportive by 90.4 and 73.7%, respectively. The psychological workup was without problems in 95.5%. CONCLUSION: Medical abortion with mifepristone and misoprostol was successful in 95.2%. Our concept of counseling and accompanying was well received and resulted in an uneventful psychological workup in most cases.     

Randomized, double-blind, controlled trial of mifepristone in capsule versus tablet form followed by misoprostol for early medical abortion

OBJECTIVE: To compare the efficacy and side-effects of mifepristone 75 mg in capsule form versus 150 mg in tablet form followed by misoprostol for medical termination of early pregnancy. STUDY DESIGN: In a prospective randomized, double-blind, placebo-controlled trial, a total of 480 women who were 49 days or less pregnant were randomized by means of a random number table to receive either two tablets in the morning and one tablet 12 h later for 2 days (group A) or three capsules orally twice daily for 2 days, the first dose being double all subsequent doses (group B). After a further 48 h, 600 microg misoprostol was given orally. Successful abortion was defined as complete abortion with no need for surgical aspiration. RESULTS: There were no significant differences between the two study groups in the rates of complete abortion (95.4% in group A versus 96.3% in group B), incomplete abortion (3.8% in group A, 3.3% in group B) and continued pregnancy (0.8% in group A, 0.4% in group B). No significant difference in the duration and amount of vaginal bleeding was observed. The incidence of side-effects, such as vomiting, nausea, headache, diarrhea and lower abdominal pain was similar in the two groups. CONCLUSIONS: Our results indicate that 75 mg mifepristone in capsule form combined with 600 microg misoprostol is as effective and safe as 150 mg mifepristone in tablet form for the termination of pregnancy up to 49 days.     

A comparison of the psychologic impact and client satisfaction of surgical treatment with medical treatment of spontaneous abortion: a randomized controlled trial

OBJECTIVE: The purpose of this study was to compare the psychologic impact and client satisfaction of routine surgical evacuation of the uterus with medical evacuation in cases of spontaneous abortion. STUDY DESIGN: This was a prospective, randomized controlled trial. Two hundred eighteen women who were admitted to a university teaching hospital after spontaneous abortion and who consented to the study were randomized to routine surgical evacuation or medical evacuation of the uterus with the use of misoprostol. General psychologic well-being, level of depression, fatigue symptoms, psychiatric morbidity, social functioning, client satisfaction, and acceptance were measured in the 2 groups. RESULTS: The 2 groups did not differ in any of the measured psychological outcomes. Significantly more participants who experienced successful evacuation of the uterus with the misoprostol protocol would choose the same mode of treatment if they were able to choose again. However, participants for whom the medical treatment failed to evacuate the uterus and subsequent surgical evacuation was required are significantly less satisfied with the treatment. CONCLUSION: Medical treatment of spontaneous abortion with misoprostol is psychologically safe and more compatible with the ethnomedical beliefs of our Chinese participants. Client satisfaction and acceptance should be taken into consideration in the evaluation of treatment outcomes.     

A comparison of 600 and 200 mg mifepristone prior to second trimester abortion with the prostaglandin misoprostol

Objective To compare the use of 600 and 200 mg mifepristone prior to second trimester termination of pregnancy with the prostaglandin misoprostol.
Design A randomised study. Setting A Scottish teaching hospital.
Participants Seventy women undergoing legal induced abortion between 13 and 20 weeks of gestation.
Intervention Administration of either 600 or 200 mg mifepristone 36 to 48 hours prior to prostaglandin.
Main outcome measure Induction-abortion interval.
Results The geometric mean induction abortion interval was 6.9 (95 % CI 5.8–8.4) h and 6.9 (95 % CI 5.8–8.2) h in the 600 and 200 mg groups, respectively (no significant difference). The median dose of misoprostol was 1600 pg (three doses) in each group. Analgesic requirements and prostaglandin-related side effects were similar between groups. Overall, 11-4% of women required surgical evacuation of the uterus as a result of retained placenta.
Conclusions The dose of mifepristone used in second trimester abortion can be reduced from 600 to 200 mg.     

A two-stage increase in the dose of misoprostol improves the efficacy of medical abortion with mifepristone and prostaglandins

Objective?To compare the efficacy and side effects of three regimens of intravaginal misoprostol for second-trimester abortion.

Methods?A total of 118 women requiring second-trimester pregnancy termination were randomly assigned to one of three treatment groups: 400?μg 3-hourly in group A (n?=?39), 600?μg 6-hourly in group B (n?=?39), and 800?μg 12-hourly in group C (n?=?40). Misoprostol tablets moistened with 3?ml of 5% acetic acid were placed into the posterior vaginal fornix.

Results?The median induction-abortion times in groups A (8?h [range: 3–64]) and B (9?h [4–81]) were significantly shorter (p?p?p?Conclusions?Misoprostol moistened with acetic acid is effective for second-trimester pregnancy termination when given vaginally 3-hourly, 6-hourly or 12-hourly. The former two regimens are significantly more effective than the latter.     

Home use of two doses of misoprostol after mifepristone for medical abortion: A pilot study in Sweden and France

Objective To test the feasibility, safety, and efficacy of home use of two doses of misoprostol for medical abortion (MA) in European settings.

Methods One hundred thirty women (100 in Sweden, 30 in France) presenting for first-trimester MA were administered oral mifepristone in the clinic and sent home with two 400 μg doses of misoprostol, along with instructions to take the misoprostol at 24 h intervals. Women were also asked to complete a daily symptom diary. Outcomes of interest included effectiveness, side-effects, and adherence to and acceptability of the home-use regimen.

Results Three women (all in France) were lost to follow-up. Of the remaining 127 women, 124 (98%) had a successful MA. All women adhered successfully to the home-use regimen, and satisfaction with home use was high (98%). Most women experienced noticeable, if transitory, side effects after both the first and second doses of misoprostol (97% and 94%, respectively).

Conclusions Misoprostol may successfully and satisfactorily be used at home as part of a MA regimen in European settings as it has been for years in the US. Further research to determine if two doses of misoprostol are more effective than a single dose would be useful.     

Emotional impact and acceptability of medical abortion with mifepristone: A German experience

In Germany, four years of experience with mifepristone as an alternative procedure to surgical abortion have revealed a still reluctant use of the new method. In the public discussion, the more participatory role of the women in the abortion procedure is often feared to have negative consequences for the emotional processing of the event. This study compares the women's criteria for selecting a method and the psychological responses before and four weeks after medical or surgical abortion. Two hundred and nineteen women answered questions regarding demographic data, motivation, medical details and social support. Additionally, the women completed the Hospital Anxiety and Depression Scale (HADS) and the Impact of Event Scale (IES). There were no differences regarding sociodemographic and reproductive characteristics among both groups. Comparing data before and a month after the abortion, our study showed a significant decline of both anxiety and depression for both abortion methods. The medical group had significantly lower entrance levels of anxiety than the surgical group. The medical regimen caused significantly more sequelae such as prolonged bleeding, pain and other side effects. However, this did not have a negative influence on the coping process. A vast majority of women in both groups evaluated choosing between different abortion methods as being highly important to them. Our study supports the consensus view that termination of an unwanted pregnancy is a positive first solution to the conflict, regardless of the chosen method. The positive outcome and high satisfaction levels among the participants illustrate the importance of an ongoing and improved accessibility of medical abortion for women in Germany.     

Home use of two doses of misoprostol after mifepristone for medical abortion: a pilot study in Sweden and France.

OBJECTIVE: To test the feasibility, safety, and efficacy of home use of two doses of misoprostol for medical abortion (MA) in European settings. METHODS: One hundred thirty women (100 in Sweden, 30 in France) presenting for first-trimester MA were administered oral mifepristone in the clinic and sent home with two 400 microg doses of misoprostol, along with instructions to take the misoprostol at 24 h intervals. Women were also asked to complete a daily symptom diary. Outcomes of interest included effectiveness, side-effects, and adherence to and acceptability of the home-use regimen. RESULTS: Three women (all in France) were lost to follow-up. Of the remaining 127 women, 124 (98%) had a successful MA. All women adhered successfully to the home-use regimen, and satisfaction with home use was high (98%). Most women experienced noticeable, if transitory, side effects after both the first and second doses of misoprostol (97% and 94%, respectively). CONCLUSIONS: Misoprostol may successfully and satisfactorily be used at home as part of a MA regimen in European settings as it has been for years in the US. Further research to determine if two doses of misoprostol are more effective than a single dose would be useful.